Breast prosthesis and method for making the same

ABSTRACT

The invention relates to a breast prosthesis for breast-amputated women with a flexible plastic body (1) comprising two plastic sheets (2, 3) connected to each other along their common edge (23) and a plastic mass (4) enclosed between the two plastic sheets (2, 3), wherein the plastic body (1) has a front side (21) formed to resemble the contour of the natural breast and a back side (31) capable of facing the torso of the person, and an elastically deformeable thin part (6) secured with its edge (611) to the back side (31) of the plastic body (1). In order to improve the wear comfort of the breast prosthesis, the thin part (6) is secured to the plastic body (1) inside the common edge (23) of the connected plastic sheets (2, 3).

TECHNICAL FIELD

The invention relates to a breast prosthesis with a flexible plasticbody comprising two plastic sheets connected to each other along theircommon edge and a plastic mass enclosed between the two plastic sheets,wherein the plastic body has a front side formed to resemble the shapeof the natural breast and a back side capable of facing the torso of thewearer, and an elastically deformeable thin part secured with its edgeto the back side of the plastic body. The invention also relates to amethod for making the breast prosthesis. Breast prosthesis of this typeare worn in bras, bikini tops, swimsuits and the like.

PRIOR ART

A breast prosthesis of this type is known from DE 44 21 516 C1. Thestate of the art provides a breast prosthesis which is very comfortableto wear and has a natural appearance. Since breast prosthesis are oftenworn for a long time and in addition simulate a part of the body whichis very important for the self esteem of the woman, even slightimprovements in the wear comfort and in the simulation of the naturalappearance, respectively, represent a significant progress.

OBJECT OF THE INVENTION

It is the object of the invention to design the breast prosthesis insuch a way that the wear comfort and the simulation of the naturalappearance, respectively, are further improved, as well as to provide amethod for the manufacture thereof.

The object is solved with the features of the claim 1 and 31,respectively. Advantageous embodiments are provided in the dependentclaims.

Since the prosthesis in the edge regions preferably only includes theplastic sheets enclosing the plastic mass, an almost continuous ornatural transition between the prosthesis and the skin of the wearer canbe achieved. This advantage of the embodiment of the invention isparticularly evident when fabric material is used for the thin part,since the thickness of the fabric material requires a steppedtransition.

Some wearers prefer to wear the breast prosthesis directly on theirskin. With the embodiment of the invention, the risk that the prosthesisslips is reduced, which could otherwise make an unnatural and thusundesirable impression. Here, the edge portion of the prosthesis is notcovered by the thin part which is made preferably of fabric material,and advantageously has a larger friction coefficient than the thin partwhen it makes contact with the skin of the wearer. This effect isenhanced by the natural moistness of the skin.

After partial amputations or after reconstruction of a new, but smallerbreast after a full amputation, cup prosthesis are preferably used whichonly simulate the contour of a portion of the natural breast. In orderto provide a transition between the remaining or reconstructed breastand the prosthesis which appears as natural and continuous as possible,the thickness of the plastic body of such cup prosthesis usuallydecreases towards the edge. As a result, the thickness and thus thestiffness of the flexible plastic body is reduced in comparison to afull prosthesis. According to the invention, the possibility for theedge of the plastic body to curl up as a result of the force created bythe tension of the thin part is reduced, since the thin part isdisplaced towards the inside. The plastic body is therefore at mostdented, but never curls. The deformation is further reduced by theincreased wall thickness of the plastic body and the increased stiffnessresulting therefrom. Preferably, the thin part is secured to the backside of the plastic body 1 to 4 cm inside the edge of the breastprosthesis. This distance can vary, preferably with the size of thebreast to be simulated and with the point of attachment.

Preferably, an opening is provided in the thin part and/or between thethin part and the plastic body for inserting filler material between thethin part and the back side of the breast prosthesis. In this way, theprosthesis can be individually fitted to the upper body, i.e. to theremaining breast or to the breast to be reconstructed, respectively. Inparticular, changes can be accommodated. In addition, the wearer herselfcan adjust the position of the filler material by trial and error forproviding a better wear comfort and fit of the prosthesis.

Preferably, the thin part is deep drawn in such a way that a tensionlessfit with the concave form of the back side of the plastic body isprovided, which has the advantage that the thin part also contactswithout tension the breast tissue which is left or remains intact aftera partial amputation, thereby providing enhanced wear comfort.

It is another advantage of the breast prosthesis of the invention thatit can be used as a cup evening out a breast, both for a breastreduction and for a breast enlargement. Furthermore, the breastprosthesis can easily be adapted to the changing volume and weight ofthe breast during the course of a step-by-step reconstruction through astep-by-step reduction of the filler material.

On the breast prosthesis of the invention, the thin part is secured tothe plastic body inside the common edge of the plastic sheets connectedto each other. In this way, the thin part is located closer to the frontpart of the breast or, expressed differently, farther inward of thebreast prosthesis. Furthermore, a material can advantageously beselected for the thin part which is molded not at all or only slightlyduring the deep drawing process, but which is elastic enough so that thethin part essentially regains the same surface area it had before thedeep drawing process. This creates an area with only slight tension. Infirst approximation, the breast prosthesis of the invention can then beregarded as an elastic hollow body. If a force is applied to an elastichollow body as to compress it in one direction, then the cross sectionalarea between the delimiting surfaces increases. This enlargement is, forexample, greatest for a cylinder or a sphere at their respectivecenters. If the envelope of the hollow body is connected along the crosssectional area, then the connection means will also be distorted whenthe cross sectional area increases. The force necessary to accomplishthis opposes the compressing force. In addition to the rigidity residingin the envelope, the body is reinforced by connecting means opposing theincrease in cross section.

In a breast prosthesis of the invention of this type, the plastic bodyis at its attachment line reinforced by the thin part, in addition tohaving its own rigidity. With the same stiffness, the breast prosthesiscan thus be constructed to have less weight, whereby the wear comfort isenhanced. In addition, the breast prosthesis can be manufactured lessexpensively. Depending on the requirement for and the size of the breastto be simulated, one, two or more thin parts can be connected to theplastic body. Through a suitable selection of the number and theplacement of the thin parts, the breast prosthesis can be optimallyfitted to resemble the features of the natural breast. Satisfactoryresults are achieved with a first thin part in the rearward third and asecond thin part in the forward third of the breast prosthesis.

In order to increase the wear comfort for women who do not desire adirect contact between the plastic sheet of the breast prosthesis andtheir skin, the thin part closest to the torso of the wearer ispreferably enlarged by a marginal section extending to the common edgeof the plastic sheets, wherein the marginal section contains preferablymicrofibers.

Advantageously, the outer edge of the marginal section is joined to theplastic body using the same method which is used for connecting the twoplastic sheets. This can be accomplished by welding or gluing. The fixedconnection between the outer edge of the marginal section and theplastic body allows the outer edge exactly to be even with the edge ofthe plastic sheets. An overhanging edge which could protrude from thegarment under which the breast prosthesis is worn, is thereby avoided.

The marginal section of the thin part is advantageously joined to theback side facing the torso of the wearer in form of a grid pattern. Thiscan, for example, be done by a welding operation using a tool having agrid pattern. A secure and slip-free fit of the thin part andconsequently of the breast prosthesis is thereby ensured. Also reducedis the danger that the breast prosthesis slides and thereby causesunnatural effects.

The breast prosthesis contacts the torso of the wearer only along themarginal region. The sensitive skin and scar tissue are to a largeextent ventilated, thereby accelerating for a freshly amputated wearerthe scarring process and promoting an environment which does notirritate the skin. The continuous movement on the body causes a suctionand pump effect which ensures an exchange of air between the skin andthe prosthesis.

Placement of the thin part inside the edge of the plastic body creates acavity capable of receiving breast tissue which is left after a partialamputation, without causing a troublesome pressure contact between thethin part and the remaining breast tissue. If, however, more breasttissue can be saved during a partial amputation than the cavity iscapable of receiving without creating a contact between the breasttissue and the thin part, then the remaining breast tissue presses lessstrongly against the thin part than is the case with a breast prosthesiswhere the thin part is secured to the edge of the plastic body.

Preferably, the thin part is made of a microfiber or a climatic fabric.Since sweat in the form of steam can penetrate such material, but isprevented from returning to the skin of the wearer when in condensedform, the skin remains comfortably dry even under considerable bodilyexertion.

Instead of joining the thin part to the plastic body by welding, thethin part can also be glued to the plastic body. Gluing also provides asecure and durable connection between the parts. The material should besecured by gluing if the material selected for the thin part cannot bewelded at all or only with great difficulty, for example, when thematerial is made entirely or in part of a natural fiber, such as cotton.

Welding the thin part to the plastic body does not necessarily mean thatthe thin part completely fuses together with the plastic body. In thisspecification, the term "welding" shall also describe an attachmentmethod wherein the thin part only fuses with the adjacent plastic sheetof the plastic body at its respective surface.

A variety of different materials can be used for the thin part. Themajor criteria for selecting the material to be used for the thin partis that the material can be easily attached to and released from theplastic body, and must have a desired elasticity and stiffness,respectively, a high tear resistance, good ability to absorb and releasemoisture, a comfortable softness and must be easy to clean. If the thinpart is to be welded to the plastic body, then the thin part ispreferably made of polyamide or polyester fibers. The thin part can bemade at least in the marginal region of cotton or of a mixture ofpolyamide and/or polyester fibers and cotton because these materials areknown for not irritating the skin. If the thin part should be capable oftransporting the moisture away from the skin surface, then the thin partis advantageously a woven or knitted fabric made of microfibers which ispervious to moisture in the form of steam, but prevents condensatedmoisture from permeating. Particularly suited are extremely finefibrillated microfibers made of polyester and polyamide. Such microfiberfabrics are known in the art as "climate fabrics". The differentsections can be made of different materials depending on the differentrequirements. For example, the front thin part in particular preferablycomprises a plastic sheet made of, for example, polyurethane.

Preferably, in the breast prosthesis there is provided an opening forinserting filler material into the cavity located between the tensionedsurface(s) and the back side facing the torso of the wearer. The openingis preferably reclosable, in particular using a Velcro closure. Theopening can be provided in the weld seam between the thin part and theback side facing the torso of the wearer or in the thin part itself. Thefiller material is preferably a padding element, in particular amicrofiber thread ball or an air-tight film ball or a foam element. Theopening is advantageous in that the padding element can be removed andenlarged.

The opening for filling the breast prosthesis preferably includes anelement for reinforcing the fabric edges. For this purpose, there isdisposed between the fabric member and the fabric tape a plastic sheetwhich is welded or glued to the fabric member and the fabric tape.Thereby a laminate comprising the fabric member, the fabric tape and theplastic sheet is created at the marginal region of the fabric member,wherein the laminate reliably protects the edge of the fabric member andalso the edge of the fabric tape from fraying, can be manufacturedeconomically, is not or is only marginally thicker than the fabricmember and the fabric tape when both the fabric member and the fabrictape are superposed, and wherein the laminate does not change theappearance of the fabric member or the appearance of the fabric tape.

Preferably, the plastic sheet(s) is (are) polyurethane films which canbe made very thin, extremely elastic and transparent and can be weldedwell to the fabric member and the fabric tape.

In addition, the fabric member and the fabric tape can be made of thesame material, preferably of a fabric made of polyamide or polyesterfibers, whereby the adhesion between the plastic sheet and the fabricmember and the adhesion between the plastic sheet and the fabric tape isidentical.

BRIEF DESCRIPTION OF THE DRAWINGS

Different embodiments of the invention are depicted in the drawings andare described in greater detail hereinafter. The thickness of theplastic sheets and the fabric member is exaggerated herein in comparisonwith the dimensions of the breast prosthesis.

It is shown in:

FIG. 1 a cross-sectional view of the breast prosthesis of the invention;

FIG. 2 a cross-sectional view of the breast prosthesis of FIG. 1,wherein filler material is inserted between the thin part and the backside of the plastic body;

FIGS. 3 to 5 a method for making a breast prosthesis of the invention,wherein the breast prosthesis is shown in cross-sectional view duringfor various fabrication steps;

FIG. 6 a cross-sectional view of the breast prosthesis of the inventionaccording to another embodiment;

FIG. 7 a cross-sectional view of another embodiment of a breastprosthesis of the invention, wherein the thin part comprises a marginalregion;

FIG. 8 a cross-sectional view of another embodiment of a breastprosthesis of the invention, wherein there are provided several thinparts;

FIGS. 9A, 9B and 9C cross-sectional views of further embodiments of abreast prosthesis of the invention, wherein there is provided a paddingelement in a cavity between the plastic body and the thin part; and

FIGS. 10A, 10B and 10C cross-sectional views of further embodiments of abreast prosthesis of the invention, wherein there is provided an openingfor removing or augmenting the padding element;

FIG. 11 a top plan view of a partial section of a fabric member with aslotted opening having a reinforced edge according to the invention; and

FIG. 12 a cross-sectional view of the fabric member depicted in FIG. 11taken along the line XII--XII, wherein in addition to the fabric member,there is also shown the fabric tape and the plastic sheet.

PREFERRED EMBODIMENTS OF THE INVENTION

The breast prosthesis depicted in FIG. 1 represents a preferredembodiment of the invention. The breast prosthesis comprises a flexible,cup-shaped plastic body 1 made of two polyurethane films 2, 3 which arewelded together along their common edge 23, and a two componentcross-linked silicone rubber mass 4 which is enclosed cavitation-freebetween the polyurethane films. The side 21 of the polyurethane film 2facing away from the silicone mass 4 has a convex shape corresponding tothe shape of the natural breast. The side 21 of the polyurethane film 2represents the front side of the plastic body 1 and thus the front sideof the breast prosthesis. The side 31 of the polyurethane film 3 facingaway from the silicone mass 4 has a concave shape, wherein the concaveshape approximately matches the contour of the front side of the plasticbody. This side 31 of the polyurethane film 3 represents the back sideof the plastic body 1 facing the body of the wearer of the prosthesis.To the back side of the plastic body 1, there is fixedly connected anelastically deformeable fabric member (thin part) 6 through at least oneweld or glue seam 7. The at least one weld or glue seam 7 extends insidethe common edge 23 of the two plastic sheets 2, 3. The seam can becontinuous or can include partial seams having in the longitudinaldirection one or more separations therebetween which can be utilized,for example, as fill opening(s) for filler material.

The depicted embodiment represents a cup prosthesis for augmenting aremaining or reconstructed breast symmetrically to the intact breast.Since a person is usually not completely symmetrical, the reproducedbreast can be reproduced somewhat larger or smaller, depending on thepreference of the wearer.

The cup prosthesis tapers off towards the edge of the plastic body inorder to preferably provide a continuous transition between the skin ofthe wearer and the prosthesis.

The back side 31 of the plastic body between the common edge 23 of thetwo plastic sheets 2, 3 and the fabric member 6 is preferably notcovered by a fabric member. This increases the friction when theprosthesis is worn directly on the skin and thereby reduces the dangerthat the prosthesis slips which could result in a disfigurement of thewearer.

For optimally tailoring the cup prosthesis to the remaining orreconstructed breast, respectively, filler material can be introducedbetween the fabric member 6 and the back side 31 of the plastic body 1covered by the fabric member 6. FIG. 2 shows the breast prosthesis ofFIG. 1 with filler material 10 inserted between the fabric member 6 andthe plastic body 1.

The fabric member 6 is preferably provided with a slotted opening 11 forintroducing the filler material between the fabric member and the backside 31 of the plastic body and for removing the filler materialtherefrom. Preferably, on the side of the fabric member 6 facing theplastic body, there is disposed an annular fabric tape in such a waythat the edges of the fabric member 6 and of the fabric tape delimitingthe opening 11 are precisely superposed.

Preferably, between the fabric member and the fabric tape, there isdisposed a plastic sheet which has the same contour as the fabric tapeand is superposed congruently with the fabric tape. The plastic sheet iswelded over its entire area to both the fabric tape and the fabricmember 6. By employing the fabric tape and the plastic sheet, the edgesof the opening 11 can be reinforced without the use of a seam.

In the following, the preferred method for making a breast prosthesis isdescribed with reference to FIGS. 3 to 5:

(A) First, the fabric member 6 is cut to size and, if necessary,provided with an opening 11. The edge of the opening is preferablyreinforced, for example by welding to a plastic sheet and a fabric tape.

(B) In the next step, the so prepared fabric member 6 is secured to aplastic sheet 3 preferably through welding. This state is shown in FIG.3. The reinforcing fabric tape is preferably disposed between theplastic sheet 3 and the fabric member 6.

(C) Subsequently, another plastic sheet 2 is placed on the side of theplastic sheet 3 facing the fabric member 6 and joined with each other,preferably by welding, along a line 23 which later forms the edge of theprosthesis, except for a fill opening which will be closed later, insuch a way that a pouch is formed. The line 23 which later forms theedge of the prosthesis, encloses the edge 7 of the fabric member 6. Thisstate of the method is shown in FIG. 4.

(D) The pouch formed in this manner is then filled with anon-crosslinked silicone rubber mass and placed in a two-part mold form12A, 12B with a recess, wherein the recess is shaped to correspond tothe front of the prosthesis which is shaped to resemble the naturalbreast. The mold form 12A, 12B is closed in the conventional fashion.During this process, the two plastic sheets 2, 3 and the fabric member 6are deep drawn. The fabric member 6 preferably comprises syntheticmaterial such that the fabric member 6 is molded during the deep-drawingprocess and preferably assumes a preformed shape corresponding to thedeep drawn back side 31. Alternately, the material can retain itsoriginal shape after the deep drawing process, whereby the breastprosthesis is stiffened by the resulting slightly stressed area. Thedeep-drawn breast prosthesis inside the mold form is shown in FIG. 5.For the sake of clarity, the reference numerals corresponding to thosein FIGS. 1 and 2 are omitted in FIG. 5.

(E) Subsequently, the silicone rubber mass is cross-linked inside a hotbox. Afterwards, the prosthesis is removed from the mold form 12A, 12Bfor finish processing, wherein in particular the marginal region of theplastic sheets are cut off up to the connection line 23 which then formsthe edge of the completed prosthesis.

The breast prosthesis depicted in FIG. 6 comprises a flexible,cup-shaped plastic body 1 including two polyurethane films 2, 3 whichare welded together along their common edge 23, and a two componentcross-linked silicone rubber mass 4 which is enclosed cavitation-freebetween the polyurethane films. The side 21 of the polyurethane film 2facing away from the silicone mass 4 has a convex shape corresponding tothe shape of the natural breast. The side 21 of the polyurethane film 2represents the front side of the plastic body 1 and thus the front sideof the breast prosthesis. The side 31 of the polyurethane film 3 facingaway from the silicone mass 4 has a concave shape, wherein the concaveshape approximately matches the contour of the front side of the plasticbody. This side 31 of the polyurethane film 3 represents the back sideof the plastic body 1 facing the body of the wearer of the prosthesis.To the back side of the plastic body 1, there is fixedly connected anelastically deformeable fabric member (thin part) 6 through a weld orglue seam 7. The weld or glue seam 7 extends inside the common edge 23of the two plastic sheets 2, 3. Consequently, the fabric member 6 formsa surface 61 which is closer to the front of the prosthesis than in abreast prosthesis wherein the fabric member is secured only to thecommon edge 23 of the two plastic sheets 2, 3. The surface area of thesurface 61 increases when pressure is applied and the shape of thebreast prosthesis changes as a result. The force required in this casegenerates a force which opposes the deformation. Since the surface 61 islocated closer to the front of the prosthesis than is the case withconventional prosthesis, i.e. the surface 61 is located more towards themiddle of the prosthesis, the prosthesis can have the same stiffnesseven if the plastic body 1 is less rigid. The weight of the prosthesiscan therefore be reduced and the prosthesis can be worn morecomfortably.

Suitably, the edge 611 of the fabric member 6 is disposed in the forwardthird of the plastic body 1.

A cavity 5 is disposed between the surface 61 and the back side of theplastic body 1 inside the surface 61. If the fabric member 6 is made ofmicrofibers or climate fabrics, respectively, sweat in vapor form whichpermeated through the fabric member, can condense in the cavity 5. Theside facing the wearer remains comfortably dry. Since the volume of thecavity 5 is rather large, the wearer stays dry even after the prosthesishas been worn for a long time.

Instead of a fixed connection between the fabric member 6 and the backside of the plastic body 1, a releasable connection can also becontemplated. A releasable connection is appropriate if the fabricmember 6 and the plastic body 1 are to be cleaned separately from eachother. A removable fabric member 6 is also advantageous if the cavity 5contains a padding member, as depicted in the embodiments of FIGS. 9A,9B, 9C, 10A and 10B and described below, which, if necessary, can beremoved, cleaned, exchanged or changed in volume. The fabric member 6can also be provided with an opening for gaining access to the cavity 5in order to reach the padding member for the above described purposes orin order to be able to insert the padding member into the cavity at all,wherein an opening may be provided in particular if the fabric member isfixedly secured to the back side of the plastic body. Instead of placingthe opening in the fabric member, the opening can also be formed bysegmenting the joint seam between the fabric member and the plasticbody. A releasable connection between the fabric member and the plasticbody can be implemented, for example, through a Velcro closure.

For the sake of brevity, parts having identical reference numbers andthe same functionality, will not be described further or will not bereferenced at all in the following description of additionalembodiments.

In the further embodiment of the breast prosthesis depicted in FIG. 7,the fabric member 6 includes, in addition to the central area 61, amarginal region 62 which is fixedly secured to the back side 31 throughtwo weld seams 7 and 8. This marginal region 62 covers also the areaproviding contact between the breast prosthesis and the skin of thewearer. In addition to the weld seams 7 and 8, the marginal region 62 isfixedly secured to the back side 31 by a grid pattern. The marginalregion 62 preferably includes a material which does not irritate theskin, most preferably a microfiber material which allows sweat in thevapor phase to penetrate, but prevents penetration in the liquid phase.Consequently, the contact region between the breast prosthesis and theskin of the wearer of the prosthesis remains dry, thereby ensuring apleasant wear comfort. In addition, air chambers are created by thegrid-like attachment, further improving the wear comfort. The ribbingcreated by the grid increases the surface area of the side of theprosthesis facing the wearer. When microfiber material is used forcovering the marginal region 62, penetrating sweat vapor condenses atthe plastic sheet 3. The ribbing provides a secure and slip-free fit ofthe material.

In FIG. 8 there is shown another embodiment of the breast prosthesis ofthe invention. This embodiment is similar to the embodiment shown inFIG. 6. In comparison to the embodiment shown in FIG. 6, there isprovided an additional thin part 6A having an area 61A. By distributingthe areas across a wide region of the height of the prosthesis, thestiffness of the plastic body can be further reduced by employing, forexample, a thinner construction, while retaining the stiffness of thebreast prosthesis. The simultaneous reduction in weight improves thewear comfort.

Suitably, the edge 611A of the additional thin part 6A is disposed inthe forward third of the plastic body 1 and that the edge 611 of thefabric member 6 is disposed in the rearward third of the plastic body 1.

In an alternate embodiment (not shown), the thin part 6 can also beomitted so that only the front region of the breast prosthesis isreinforced by the fabric member 6A. A breast prosthesis of this type isparticularly suited for women who underwent a partial amputation where alarge part of the breast was not removed. Depending on the supportrequirements, additional thin parts 6A with areas 61A can be fixedly orreleasably secured to the plastic body 1.

In FIGS. 9A, 9B and 9C, there are shown additional embodiments of thebreast prosthesis of the invention corresponding to the embodiments ofFIGS. 6, 7 and 8. Only differences with the aforedescribed embodimentswill be described hereinafter. For the description of parts alreadydiscussed, reference is made to the description of the above figures. Inthe embodiments of FIGS. 9A, 9B and 9C, a padding member 10 is disposedinside the cavity 5. This padding member 10 can, for example, be apolyurethane film filled with air or a microfiber thread ball or a foambody. The padding member stabilizes the breast prosthesis furtherwithout adding significant weight. As a result, the silicone portion orthe space between the plastic sheets 2 and 3 could be reduced further,making it possible to manufacture a lighter prosthesis at less cost.Thereby, the wear comfort is further enhanced.

In FIGS. 10A and 10B, there are shown additional embodiments of theprosthesis of the invention corresponding to the embodiment of FIG. 6and FIG. 7, respectively. Only differences with the aforedescribedembodiments will be described. For the description of parts alreadydiscussed, reference is made to the description of the above figures.The embodiment of FIG. 10A comprises as a padding member a microfiberthread ball 10. The thread ball 10 can be removed or enlarged through anopening 11 formed in the area 61. In this way, the stiffness andtension, respectively, can be matched to the human breast to besimulated. The embodiment of FIG. 10B comprises as a padding member apolyurethane ball. Additional padding material can be added or thepadding material can be removed through the opening 11. This designprovides the above advantages. With both designs, the padding memberscan be made of other padding materials. These include foam or fiberfill. A padding member filled with air or with another gas or with afluid can also be employed. Such padding member can be provided with avalve allowing to change the volume and/or the stiffness of the paddingmember.

Using a padding member having a changeable shape and volume has theadditional advantage that the area formed by the fabric member can beindividually matched to the tissue remaining after a partial amputation.An example wherein the area of the fabric member is individually matchedby appropriately shaping the padding member, is shown in FIG. 10C.

In FIGS. 11 and 12, there is shown an advantageous embodiment of theedge of opening 102 which is referenced as 11 in the other figures,wherein the edge is reinforced by placing a plastic sheet 105 betweenthe fabric member 101 (referenced above as 6) and a fabric tape 104disposed along the edge 103 of the fabric, and by welding or gluing theplastic sheet 105 to the fabric member 101 and the fabric tape 104. Theplastic sheet is preferably a polyurethane film and the fabric member101 and the fabric tape 104 are preferably made of the same material. Itshould be noted that the thickness of the three elements is exaggeratedand that after welding, the plastic sheet in particular willrealistically be no longer noticeable in cross section in comparison tothe fabric member and the fabric tape.

The fabric member 101 is provided with a slotted opening 102, with theedge 103 of the opening 102 reinforced by placing on the back side ofthe fabric member 101 an annular fabric tape 104 in such a way that theedges of the fabric member 101 delimiting the opening 102 and of thefabric tape 104 are precisely superposed.

As seen from FIG. 12, between the fabric member 101 and the fabric tape104, there is placed in congruent superposition with the fabric tape 104a plastic sheet 105 having the same contour as the fabric tape 104. Theplastic sheet 105 is welded over its entire area to both the fabricmember 101 and the fabric tape 104. In FIG. 12 as well as in the otherFigures, the weld joints are indicated by heavy lines 106.

In FIG. 11, the region of the fabric tape 104, the plastic sheet 105 andthe weld joints are indicated by the broken line.

As depicted in FIG. 12, the weld joint can be constructed in such a waythat the three members only melt close to their respective surfaces. Itis also possible to design the weld joint so that all three memberscompletely fuse together.

What is claimed is:
 1. A breast prosthesis, comprising:a flexible plastic body including a first plastic sheet member and a second plastic sheet member joined to each other along a common edge, a plastic mass enclosed between the first and second plastic sheet members to form a concave cavity, wherein the plastic body has a front face formed to resemble the shape of a natural breast and a back face for facing towards the torso of a wearer; and a first elastically deformable thin part secured to the back face of the plastic body which faces towards the torso of the wearer, at a distance, in a range of from 1 to 4 cm from the common edge of the joined first and second plastic sheet members.
 2. The breast prosthesis according to claim 1 wherein the edge of the thin part is secured to the back face of the plastic body by at least one weld seam.
 3. The breast prosthesis according to claim 1 wherein the edge of the thin part is secured to the back face by a glued seam.
 4. The breast prosthesis according to claim 1 wherein the thin part is secured to the back face of the plastic body only along the edge of the thin part.
 5. The breast prosthesis according to claim 1, wherein the thin part defines a surface area which in an unstressed state is greater than an area demarcated by the edge of the thin part secured to the plastic body.
 6. The breast prosthesis according to claim 1 wherein the thin part defines a surface area which in an unstressed state essentially corresponds to an area of the back face of the plastic body demarcated by the edge of the thin part secured to the plastic body.
 7. The breast prosthesis according to claim 1 wherein the thin part is a fabric member.
 8. The breast prosthesis according to claim 1 wherein the thin part and the back face of the plastic body define a hollow space, said thin part being provided with an opening for inserting filler material in the hollow space between the thin part and the back (side) face of the plastic body.
 9. The breast prosthesis according to claim 8 wherein the opening has the shape of a slit which is demarcated by an edge of the thin part, said edge of the thin part around the opening being reinforced by a fabric tape.
 10. The breast prosthesis according to claim 9, and further comprising a plastic sheet disposed between the thin part and the fabric tape and joined to the thin part and the fabric tape by a process selected from the group consisting of welding and gluing.
 11. The breast prosthesis according to claim 9 wherein the thin part and the fabric tape are made of a same material.
 12. The breast prosthesis according to claim 1 wherein the plastic sheet members are polyurethane films.
 13. The breast prosthesis according to claim 1 wherein the thin part in conjunction with the back face of the plastic body forms a cavity.
 14. The breast prosthesis according to claim 1 wherein the thin part comprises a marginal region surrounding a central area and extending to the common edge of the first and second plastic sheet members.
 15. The breast prosthesis according to claim 14 wherein the marginal region comprises an edge terminating at the common edge of the plastic sheet members, said edge of the marginal region being fixedly secured to the common edge of the plastic sheet members.
 16. The breast prosthesis according to claim 15 wherein the edge of the marginal region is welded to the plastic body through a weld seam.
 17. The breast prosthesis according to claim 15 wherein the edge of the marginal region is glued to the plastic body.
 18. The breast prosthesis according to claim 14 wherein the edge of the marginal region is fixedly secured to the back face of the plastic body in the form of a grid pattern.
 19. The breast prosthesis according to claim 1, and further comprising at least one second thin part having an edge which is so affixed to the back face of the plastic body that the first thin part and the second thin part are spaced from one another.
 20. The breast prosthesis according to claim 8 wherein the edge of the first thin part is secured to the back face of the plastic body by a weld seam or glue seam, said opening being formed by an interruption in the weld seam or glue seam.
 21. The breast prosthesis according to claim 8 wherein the opening is closable.
 22. The breast prosthesis according to claim 13, and further comprising a padding member disposed in the cavity.
 23. The breast prosthesis according to claim 19 wherein at least one of the first and second thin parts is a fabric member.
 24. The breast prosthesis according to claim 23 wherein the fabric member comprises at least one material selected from the group consisting of polyamide fibers, polyester fibers and cotton.
 25. The breast prosthesis according to claim 23 wherein the fabric member is made of a material selected from the group consisting of woven fabric and knitted fabric made of microfibers.
 26. The breast prosthesis according to claim 25 wherein the microfibers are made of a material selected from the group consisting of polyester and polyamide.
 27. The breast prosthesis according to claim 19 wherein at least one of the first and second thin parts is a plastic sheet.
 28. The breast prosthesis according to claim 27 wherein the first thin part is a plastic sheet and the second thin part is a fabric member.
 29. The breast prosthesis according to claim 2 wherein the edge of the thin part is partially secured to the back face of the plastic body by the weld seam.
 30. A breast prosthesis, comprising:a flexible plastic body including a first plastic sheet member and a second plastic sheet member joined to each other along a common edge; a plastic mass enclosed between the first and second plastic sheet members to form a concave cavity, wherein the plastic body has a front face formed to resemble the shape of a natural breast and a back face for facing towards the torso of a wearer; and an elastically deformable thin part secured to the back face of the plastic body at a distance to the common edge of the joined first and second plastic sheet members; wherein the thin part and the back face of the plastic body define a hollow space, said thin part being provided with an opening for inserting filler material in the hollow space between the thin part and the back face of the plastic body, wherein the opening has the shape of a slit which is demarcated by an edge of the thin part, said edge of the thin part around the opening being reinforced by a fabric tape at the edge of the opening.
 31. A breast prosthesis, comprising:a flexible plastic body including a first plastic sheet member and a second plastic sheet member joined to each other along a common edge; a plastic mass enclosed between the first and second plastic sheet members to form a concave cavity, wherein the plastic body has a front face formed to resemble the shape of a natural breast and a back face for facing towards the torso of a wearer; and an elastically deformable thin part secured to the back face of the plastic body at a distance to the common edge of the joined first and second plastic sheet members, wherein the thin part and the back face of the plastic body define a hollow space, said thin part being provided with an opening for inserting filler material in the hollow space between the thin part and the back face of the plastic body; wherein the opening has the shape of a slit which is demarcated by an edge of the thin part, said edge of the thin part around the opening being reinforced by a fabric tape at the edge of the opening; and further comprising a plastic sheet disposed between the thin part and the fabric tape and joined to the thin part and the fabric tape by a process selected from the group consisting of welding and gluing.
 32. A breast prosthesis, comprising:a flexible plastic body including a first plastic sheet member and a second plastic sheet member joined to each other along a common edge; a plastic mass enclosed between the first and second plastic sheet members to form a concave cavity, wherein the plastic body has a front face formed to resemble the shape of a natural breast and a back face for facing towards the torso of a wearer; and a elastically deformable thin part secured to the back face of the plastic body at a distance to the common edge of the joined first and second plastic sheet members, wherein the thin part and the back face of the plastic body define a hollow space, said thin part being provided with an opening for inserting filler material in the hollow space between the thin part and the back face of the plastic body; wherein the opening has the shape of a slit which is demarcated by an edge of the thin part, said edge of the thin part around the opening being reinforced by a fabric tape at the edge of the opening, wherein the thin part and the fabric tape are made from the same material. 